Abbott Vascular Medical Device Registry
This study is an observational registry looking at how Abbott Vascular medical devices are used in real-world settings. It aims to confirm the safety and performance of devices like coronary and peripheral stents, pacing catheters, and vascular plugs. Researchers will track how people who receive these devices are doing over time. The study is open to adults aged 18 and older who are having or have had a procedure using one of these Abbott devices. Success in this study means understanding how many participants experience serious events like death, heart attack (myocardial infarction), or needing another procedure on the treated area (target lesion revascularization) at different time points after their procedure. The current status of this study is unclear.
- Study design
- This is an observational study that plans to include 3784 participants. It is an open-label registry, meaning both you and the study team will know which devices are being used.
- What's involved
- You would be included in the study if you have a planned or completed procedure using an Abbott device and are willing to follow a specified follow-up schedule.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for outcomes like death, heart attack, or needing another procedure on the treated area, measured during the procedure, at 30 days, and at 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Abbott Vascular Medical Device Registry
At a glance
Conditions
Where it's being run
37 sites across 31 statesStudy leadership
- Chananit Hutson, PhD · STUDY_DIRECTOR · Abbott Medical Devices
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
- Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)30 days
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
- Coronary Stents - Number of participants with composite of all-cause death, MI or target lesion revascularization (TLR)12 months
Composite of all-cause death, MI or target lesion revascularization (TLR) will be assessed among the patients who receive Coronary Stents.
- Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLRDuring procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
- Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR30 days
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
- Peripheral Stents - Number of participants with composite of all-cause death, amputation, and TLR12 months
Composite of all-cause death, amputation, and TLR will be assessed among the patients who receive Peripheral Stents.
- Peripheral Stents (Renal Indication) - Number of participants with composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLRDuring procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR will be assessed among the patients who receive Peripheral Stents (Renal Indication).
- Peripheral Stents (Renal Indication) - Number of participants with composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR30 days
Composite of all-cause death, ipsilateral nephrectomy, Embolic events resulting in kidney damage or TLR will be assessed among the patients who receive Peripheral Stents (Renal Indication).
- Peripheral Stents (Renal Indication) - Number of participants with composite of TLR12 months
Composite of TLR will be assessed among the patients who receive Peripheral Stents (Renal Indication).
- Pacing Catheters - Number of participants with composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation)During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of potential complications (venous thrombosis, pulmonary emboli, arrhythmias, perforation) will be assessed among the patients who receive Pacing Catheters.
- Pacing Catheters - Loss of capture (assessed based on physiological parameter-ECG)During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Loss of capture (average time of loss of capture across patients) will be assessed among the patients who receive Pacing Catheters. ECG is used to measure whether the pacing device stimulates the heart. Absence of a stimulation is considered a loss of capture.
- Vascular Plugs - Number of participants with composite of potential complications (Implant success, occlusion success, migration)During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of potential complications including implant success, occlusion success, migration will be assessed among the patients who receive Vascular Plugs.
- Vascular Plugs - Number of participants with composite of occlusion success and migration30 days
Composite of occlusion success and migration will be assessed among the patients who receive Vascular Plugs.
- Fractional flow reserve - Number of participants with composite of vessel dissection, perforation, and thromboembolismDuring procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of vessel dissection, perforation, and thromboembolism during procedure will be assessed among the patients who receive Fractional flow reserve (FFR).
- Fractional flow reserve - Number of participants with signal drift (Signal drift between measurements (Pd/Pa** pressure drift >0.03; <0.97 or >1.03)During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Signal drift (Signal drift between measurements (Pd/Pa\*\* pressure drift \>0.03; \<0.97 or \>1.03) will be assessed among the patients who receive FFR.
- Optical Coherence Tomography Products - Number of participants with Intraprocedural complications (number of dissections ≥type B, slow flow or no reflow, thrombus, abrupt closure, perforation)During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Intraprocedural complications will be assessed among the patients who receive Optical Coherence Tomography (OCT).
- Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality pre-PCIDuring procedure - Before the stent is implanted (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Successful crossing and image quality pre- PCI will be assessed among the patients who receive OCT.
- Optical Coherence Tomography Products - Number of participants with Successful crossing and image quality post-PCIDuring procedure - Between 10-30 minutes post-PCI (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Successful crossing and image quality post-PCI will be assessed among the patients who receive OCT.
- Peripheral Dilatation Catheters - Number of participants with Composite of major adverse eventsDuring procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of major adverse events (e.g., distal embolization, dissection, perforation, amputation primary to balloon usage, total occlusion, abrupt closure, renal failure primary to balloon usage will be assessed among the patients who receive Peripheral Dilatation Catheters.
- Peripheral Dilatation Catheters - Number of participants with Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) (assessed based on physiological parameters)During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) will be assessed among the patients who receive Peripheral Dilatation Catheters. Device success can be summarized as the successful treatment with the device.
- Coronary Guidewires - Number of participants with Composite of major adverse eventsDuring procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Coronary Guidewires.
- Coronary Guidewires - Number of participants with Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion) (assessed based on physiological parameters)During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion will be assessed among the patients who receive Coronary Guidewires. Device success can be summarized as the successful treatment with the device.
- Peripheral Guidewires - Number of participants with Composite of major adverse eventsDuring procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of major adverse events (e.g., vessel perforation, dissection, occlusion, embolism) will be assessed among the patients who receive Peripheral Guidewires.
- Peripheral Guidewires - Number of participants with Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion) (assessed based on physiological parameters)During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Device success (Successfully placed, Successfully introduce/position diagnostic/interventional device, Successfully reach/cross target lesion will be assessed among the patients who receive Peripheral Guidewires. Device success can be summarized as the successful treatment with the device.
- Coronary Dilatation Catheters - Number of participants with Composite of major adverse eventsDuring procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of major adverse events (e.g., distal embolization, dissection, perforation, amputation primary to balloon usage, total occlusion, abrupt closure, renal failure primary to balloon usage will be assessed among the patients who receive Coronary Dilatation Catheters.
- Coronary Dilatation Catheters - Number of participants with Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) (assessed based on physiological parameters)During procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Device success (Successful delivery, Successful inflation, Successful deflation, Successful withdrawal) will be assessed among the patients who receive Coronary Dilatation Catheters. Device success can be summarized as the successful treatment with the device.
- Vessel Closure Devices - Number of participants with Composite of access complicationsDuring procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Composite of access complications (e.g., hematoma, stenosis/occlusion, infection, access site bleeding) will be assessed among the patients who receive Vessel Closure Devices.
- Vessel Closure Devices - Number of participants with Successful hemostasis Major and minor bleedingDuring procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Successful hemostasis Major and minor bleeding will be assessed among the patients who receive Vessel Closure Devices.
- Vessel Compression Devices - Number of participants with Major and minor bleedingDuring procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Major and minor bleeding will be assessed among the patients who receive Vessel Compression Devices.
- Vessel Compression Devices - Number of participants with Complications including: pseudoaneurysm, hematoma (>5cm) in diameter, Hb drop>20 g/L, extended compression time >6 hours, blood transfusion required, bleeding requiring surgical procedureDuring procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Complications including: pseudoaneurysm requiring treatment, hematoma (\>5cm) in diameter, Hb drop\>20 g/L, extended compression time \>6 hours, blood transfusion required, bleeding requiring surgical procedure will be assessed among the patients who receive Vessel Compression Devices.
- Vascular Access Introducers - Incidence of safety issuesDuring procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Incidence of safety issues (e.g., bleeding, air embolism, hematoma, vessel damage (dissection, perforation, pseudoaneurysm), infection, thrombosis, AV fistula, occlusion, radial artery spasm) will be assessed among the patients who receive Vascular Access Introducers.
- Vascular Access Introducers - Incidence of performance issuesDuring procedure (Start of procedure: defined as time a guidewire first enters the vasculature. End of procedure: defined as vessel closure following the index procedure)
Incidence of performance issues (e.g., unable to introduce other devices, failure to maintain hemostasis valve integrity, air leakage, bending or kinking of introducer, difficulty inserting/removing the sheath, device breakage detachment or separation, issue with an associated accessory) will be assessed among the patients who receive Vascular Access Introducers.